Effect of Bakri balloon tamponade combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension undergoing cesarean delivery.

OBJECTIVE: To investigate the effect of Bakri balloon tamponade (BBT) combined with different suture methods on preventing postpartum hemorrhage in women with pregnancy-induced hypertension (PIH) undergoing cesarean delivery (CD). METHODS: This randomized, double-blind, controlled trial was conducted at The First Affiliated Hospital of Xingtai Medical College from October 2020 to June 2023. Patients with PIH who had persistent bleeding after CD and were unresponsive to uterine contractions, sutures, or uterine disconnection procedures were eligible participants. Eligible participants were randomly assigned to control and study groups, with 50 patients in each group. The control group used BBT combined with B-lynch uterine compression sutures, while the study group used BBT combined with modified Hayman suture. Intraoperative and postoperative bleeding and changes in vital signs were compared between the 2 groups. Moreover, changes in inflammation levels, coagulation function, and sex hormone levels were compared between the 2 groups before and after surgery. RESULTS: A total of 122 patients with persistent bleeding after CD were recruited, of whom 22 were excluded (16 cases of uterine contractions and/or local uterine myometrial sutures for hemostasis, 4 cases of preoperative uterine artery embolization, and 2 cases of uterine malformations). The intraoperative blood loss, postoperative blood loss at 2 hours, postoperative blood loss at 24 hours, and decrease in red blood cell and hemoglobin in the study group were significantly lower than those in the control group (P < .05). After surgery, the levels of inflammation, coagulation function, and sex hormone in both groups improved compared to before surgery, and the study group was significantly better than the control group (P < .05). In addition, the incidence of postoperative adverse events in the study group was significantly lower than that in the control group (P < .05). CONCLUSIONS: The hemostatic effect of BBT combined with B-lynch uterine compression sutures is comparable to that of BBT combined with modified Hayman suture for postpartum hemorrhage in pregnant women with PIH undergoing CD, but the latter has less blood loss, attenuated inflammatory response, reduced impact on coagulation function and ovarian function, and a lower incidence of adverse events.

Balões de tamponamento intrauterino na hemorragia pós-parto ­ Atualizações / Uterine balloon tamponade in postpartum hemorrhage ­ Updates

A hemorragia pós-parto continua sendo uma condição relacionada a elevada morbimortalidade materna, sendo essenciais o diagnóstico precoce e o início do tratamento farmacológico. Em caso de falha, os balões de tamponamento uterino são uma alternativa eficiente, com aplicabilidade crescente na prática clínica. Esses dispositivos são seguros, apresentam baixa incidência de eventos adversos e reduzem as taxas de procedimentos cirúrgicos. Existe uma ampla variedade de modelos, tanto industriais quanto artesanais, com acúmulo de relatos na literatura demonstrando sua eficácia. Este artigo descreve os principais balões intrauterinos, com ênfase nos modelos mais novos, aplicabilidade, taxas de sucesso e eventos adversos.(AU)

Postpartum hemorrhage continues to be a condition related to high maternal morbimortality, early diagnosis and initiation of pharmacological treatment are essential. In case of failure, uterine balloon tamponade is an efficient alternative, with increasing applicability in clinical practice. These devices are safe, have a low incidence of adverse events and reduce the overall rates of surgical procedures. There is a wide variety of models, both industrial and artisanal, with an accumulation of reports in the literature demonstrating their effectiveness. This article describes the main intrauterine balloons, with an emphasis on newer models, applicability, success rates and adverse events.(AU)

Risk Factors for Intrauterine Tamponade Failure in Postpartum Hemorrhage.

OBJECTIVE: To identify factors associated with intrauterine tamponade failure after vaginal or cesarean delivery. METHODS: This was a nationwide population-based cohort study that used data from the French Programme de Médicalisation des Systèmes d'Information. This study compared the failure and effectiveness of intrauterine tamponade among all women who received the procedure in France from January 1, 2019, to December 31, 2019. Failure was defined as the use of a second-line method (uterine artery embolization, conservative or radical surgery, or death) within 7 days of intrauterine tamponade. Factors associated with intrauterine tamponade failure were identified by univariate analyses and tested using multivariate generalized logistic regression models (with a random intercept on institution) to obtain adjusted odds ratio (aOR) and 95% CI statistics. RESULTS: A total of 39,193 patients presented with postpartum hemorrhage in 474 French maternity wards. Of these patients, 1,761 (4.5%) received intrauterine tamponade for persistent bleeding. The effectiveness rate of intrauterine tamponade was 88.9%. For 195 women (11.1%), a second-line method was indicated. Patients for whom intrauterine tamponade failed had a higher maternal age, a lower mean gestational age, and more frequent instances of placental abnormalities, preeclampsia, cesarean birth, and uterine rupture. The multivariate analysis revealed that cesarean birth (aOR 4.2; 95% CI 2.9-6.0), preeclampsia (aOR 2.3; 95% CI 1.3-4.0), and uterine rupture (aOR 14.1; 95% CI 2.4-83.0) were independently associated with intrauterine tamponade failure. CONCLUSION: Cesarean delivery, preeclampsia, and uterine rupture are associated with intrauterine tamponade failure in the management of postpartum hemorrhage.

Bakri Balloon: an easy, useful and effective option for the treatment of postpartum haemorrhage.

We report our postpartum haemorrhage protocol focussing on the use of Bakri Balloon, describing its placement and affixing method, effectiveness rates, risk factors that might contribute to Bakri Balloon's failure and complications associated. We designed a retrospective study including 147 cases where a Bakri Balloon was necessary to control the postpartum uterine bleeding to assess the efficacy and to determine which clinical, obstetric or delivery variables could be associated with successful treatment. Failed treatment was defined when surgery or any other technique was needed after a Bakri Balloon placement in order to control uterine bleeding. For statistical analysis, we developed a descriptive analysis and a univariate logistic regression study.IMPACT STATEMENTWhat is already known on this subject? Postpartum haemorrhage is one of the most severe situations in the immediate postpartum period entailing a major cause of maternal morbimortality if an accurate and quick intervention is not carried out.What do the results of this study add? The use of Bakri Balloon was effective in 94.6% of patients. No statistically significant differences were found in the success rates according to obstetric or delivery characteristics. No major complications occurred due to the placement of a Bakri Balloon. In the failure group, blood loss was significantly higher and all required blood products transfusion.What are the implications of these findings for clinical practice and/or further research? Bakri Balloon is an easy-to-use device that provides an effective therapeutic alternative to more aggressive techniques in postpartum haemorrhages when medical treatment fails. Obstetrics or delivery characteristics should not entail a contraindication in its use. A continuous training system based on an agreed protocol is recommended in order to guarantee the best care possible.

Placenta accreta spectrum disorder: a comparison between fertility-sparing techniques and hysterectomy.

This study aimed to compare fertility-sparing interventions and hysterectomy among women with placenta accreta spectrum disorder (PAS) who underwent caesarean deliveries. We retrospectively reviewed the data, and classified 148 patients as follows: group B: Bakri balloon without resection (n = 83); group R: segmental uterine resection (n = 23); and group H: hysterectomy (n = 42). The groups differed significantly with respect to operative time, transfused blood products, and post-operative intensive care unit and hospital stays. Morbidity was the highest in group H. The aforementioned parameters did not differ between Groups B and R. Groups R and H differed regarding the operative time, post-operative hospital stay, and transfused blood products. Although the treatment modality and PAS severity differed between the groups of patients with preserved fertility, the surgical outcome parameters did not differ. Hence, the effectiveness of these approaches may be similar without foregoing patient safety.IMPACT STATEMENTWhat is already known on this subject? As caesarean delivery rates have increased worldwide, the incidence of placenta accreta spectrum disorder (PAS), which has high morbidity and mortality rates, has also risen. Planned caesarean hysterectomy is recommended to reduce mortality and morbidity, but fertility is lost.What do the results of this study add? The severity of PAS can range from mild to severe. A patient-tailored approach, which was based on the intra-operative findings and used either a Bakri balloon tamponade or segmental uterine resection, reduced morbidity and preserved fertility.What are the implications of these findings for clinical practice and/or further research? Instead of adhering to the conventional approach that involves an elective caesarean hysterectomy based on antenatal imaging, more suitable approaches should be considered from the spectrum of haemostatic and fertility-preserving options available, while considering a surgeon's experience, the intra-operative findings, and patients' needs.

[Intrauterine balloon tamponade combined with temporary abdominal aortic balloon occlusion in the management of women with placenta accreta spectrum:a randomized controlled trial].

Objective: To access the effectiveness and safety of the intrauterine balloon tamponade verse gauze packing combined with temporary abdominal aortic balloon occlusion in the management of placenta accreta spectrum (PAS). Methods: This was an open-label, randomized controlled trial conducted in Nanjing Drum Tower Hospital. The patients suspected with PAS for uterine preservation surgery under the multidisciplinary team care were recruited between Aug 2015 and Jan 2018. When bleeding could not be achieved after fetus delivered, and a temporary abdominal aortic balloon occlusion and the compression sutures as needed, the women were randomly allocated 1∶1 into balloon tamponade (n=81) or gauze packing (n=80) group. The primary outcome was successful bleeding arrests by avoiding second line surgeries. The secondary outcomes included the volume of blood loss during and after cesarean section, the rate of PPH, incidence and amount of blood transfusion, hysterectomy, postpartum pain, ICU admission, need for re-laparotomy, and the length of hospital stay, readmission, and interventional radiology complications. Results: All the women [100% (81/81)] in the balloon group were obtained hemostasis without further intervention, significantly higher than 88% (70/80) in the gauze group (P=0.001). Before uterine tamponade, blood loss were 820 ml (620-1 230) ml and 850 ml (605-1 442) ml, while placenta bed were sutured in 96%（78/81, 77/80） respectively (P>0.05).The proportion of blood loss≥1 000 ml was higher in the gauze group than that in the balloon group (P=0.006). Maternal adverse events involving total blood loss, puerperal morbidity and postpartum pain occurred more frequently in the gauze group (P<0.05). The following outcome showed no statistically significant difference between the two groups: the vascular occlusion time, the dose of radiation, and interventional radiology complication (P>0.05). The median volume infused into the lower and upper balloons is 70 ml (50-100 ml) and 180 ml (100-240 ml). Conclusions: Incrauterine balloon tamponade is as effective as gauze packing in hemostasis following the placenta delivery in PAS. Compared with gauze packing, the uterine balloon tamponade is more effective.

Mechanical and surgical interventions for treating primary postpartum haemorrhage.

BACKGROUND: Primary postpartum haemorrhage (PPH) is commonly defined as bleeding from the genital tract of 500 mL or more within 24 hours of birth. It is one of the most common causes of maternal mortality worldwide and causes significant physical and psychological morbidity. An earlier Cochrane Review considering any treatments for the management of primary PPH, has been split into separate reviews. This review considers treatment with mechanical and surgical interventions. OBJECTIVES: To determine the effectiveness and safety of mechanical and surgical interventions used for the treatment of primary PPH. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (26 July 2019) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) of mechanical/surgical methods for the treatment of primary PPH compared with standard care or another mechanical/surgical method. Interventions could include uterine packing, intrauterine balloon insertion, artery ligation/embolism, or uterine compression (either with sutures or manually). We included studies reported in abstract form if there was sufficient information to permit risk of bias assessment. Trials using a cluster-RCT design were eligible for inclusion, but quasi-RCTs or cross-over studies were not. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and risk of bias, independently extracted data and checked data for accuracy. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included nine small trials (944 women) conducted in Pakistan, Turkey, Thailand, Egypt (four trials), Saudi Arabia, Benin and Mali. Overall, included trials were at an unclear risk of bias. Due to substantial differences between the studies, it was not possible to combine any trials in meta-analysis. Many of this review's important outcomes were not reported. GRADE assessments ranged from very low to low, with the majority of outcome results rated as very low certainty. Downgrading decisions were mainly based on study design limitations and imprecision; one study was also downgraded for indirectness. External uterine compression versus normal care (1 trial, 64 women) Very low-certainty evidence means that we are unclear about the effect on blood transfusion (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.66 to 8.23). Uterine arterial embolisation versus surgical devascularisation plus B-Lynch (1 trial, 23 women) The available evidence for hysterectomy to control bleeding (RR 0.73, 95% CI 0.15 to 3.57) is unclear due to very low-certainty evidence. The available evidence for intervention side effects is also unclear because the evidence was very low certainty (RR 1.09; 95% CI 0.08 to 15.41). Intrauterine Tamponade Studies included various methods of intrauterine tamponade: the commercial Bakri balloon, a fluid-filled condom-loaded latex catheter ('condom catheter'), an air-filled latex balloon-loaded catheter ('latex balloon catheter'), or traditional packing with gauze. Balloon tamponade versus normal care (2 trials, 356 women) One study(116 women) used the condom catheter. This study found that it may increase blood loss of 1000 mL or more (RR 1.52, 95% CI 1.15 to 2.00; 113 women), very low-certainty evidence. For other outcomes the results are unclear and graded as very low-certainty evidence: mortality due to bleeding (RR 6.21, 95% CI 0.77 to 49.98); hysterectomy to control bleeding (RR 4.14, 95% CI 0.48 to 35.93); total blood transfusion (RR 1.49, 95% CI 0.88 to 2.51); and side effects. A second study of 240 women used the latex balloon catheter together with cervical cerclage. Very low-certainty evidence means we are unclear about the effect on hysterectomy (RR 0.14, 95% CI 0.01 to 2.74) and additional surgical interventions to control bleeding (RR 0.20, 95% CI 0.01 to 4.12). Bakri balloon tamponade versus haemostatic square suturing of the uterus (1 trial, 13 women) In this small trial there was no mortality due to bleeding, serious maternal morbidity or side effects of the intervention, and the results are unclear for blood transfusion (RR 0.57, 95% CI 0.14 to 2.36; very low certainty). Bakri balloon tamponade may reduce mean 'intraoperative' blood loss (mean difference (MD) -426 mL, 95% CI -631.28 to -220.72), very low-certainty evidence. Comparison of intrauterine tamponade methods (3 trials, 328 women) One study (66 women) compared the Bakri balloon and the condom catheter, but it was uncertain whether the Bakri balloon reduces the risk of hysterectomy to control bleeding due to very low-certainty evidence (RR 0.50, 95% CI 0.05 to 5.25). Very low-certainty evidence also means we are unclear about the results for the risk of blood transfusion (RR 0.97, 95% CI 0.88 to 1.06). A second study (50 women) compared Bakri balloon, with and without a traction stitch. Very low-certainty evidence means we are unclear about the results for hysterectomy to control bleeding (RR 0.20, 95% CI 0.01 to 3.97). A third study (212 women) compared the condom catheter to gauze packing and found that it may reduce fever (RR 0.47, 95% CI 0.38 to 0.59), but again the evidence was very low certainty. Modified B-Lynch compression suture versus standard B-Lynch compression suture (1 trial, 160 women) Low-certainty evidence suggests that a modified B-Lynch compression suture may reduce the risk of hysterectomy to control bleeding (RR 0.33, 95% CI 0.11 to 0.99) and postoperative blood loss (MD -244.00 mL, 95% CI -295.25 to -192.75). AUTHORS' CONCLUSIONS: There is currently insufficient evidence from RCTs to determine the relative effectiveness and safety of mechanical and surgical interventions for treating primary PPH. High-quality randomised trials are urgently needed, and new emergency consent pathways should facilitate recruitment. The finding that intrauterine tamponade may increase total blood loss > 1000 mL suggests that introducing condom-balloon tamponade into low-resource settings on its own without multi-system quality improvement does not reduce PPH deaths or morbidity. The suggestion that modified B-Lynch suture may be superior to the original requires further research before the revised technique is adopted. In high-resource settings, uterine artery embolisation has become popular as the equipment and skills become more widely available. However, there is little randomised trial evidence regarding efficacy and this requires further research. We urge new trial authors to adopt PPH core outcomes to facilitate consistency between primary studies and subsequent meta-analysis.

Effects of early second-look hysteroscopy combined with intrauterine balloon dilatation on reproductive outcomes for women with intrauterine adhesions.

OBJECTIVE: To investigate the effect of early second-look office hysteroscopy combined with intrauterine balloon dilatation on prognosis and pregnancy rate for women with intrauterine adhesions. METHODS: A retrospective analysis of 156 women diagnosed with intrauterine adhesions by hysteroscopy at Shenyang Women's and Children's Hospital, China, from April 2017 to January 2019. The study women underwent intrauterine balloon dilatation 10 days after transcervical resection of adhesion (TCRA) and hysteroscopy 20 days after TCRA (n=81). The control women underwent hysteroscopy 3 months after TCRA (n=75). Estrogen and aspirin were routinely administered postoperatively to all women. Data, including American Fertility Society (AFS) scores assessed by hysteroscopy, endometrial thickness measured by ultrasound, and menstruation and pregnancy outcomes assessed by interview, were compared between the two groups. RESULTS: The degree of intrauterine adhesions, menstrual status, and endometrial thickness were improved in both groups after TCRA. Greater improvement in AFS score, menstruation, and endometrial thickness was observed in the study group than in the control group. After follow-up, more women in the study group achieved pregnancy (48.1% vs 30.7%, P<0.05). CONCLUSION: Early second-look of hysteroscopy combined with intrauterine balloon dilatation after hysteroscopic TRCA might improve the prognosis and postoperative pregnancy rate for women with intrauterine adhesions.

Balloon tamponade for successful emergency cervical cerclage.

AIM: To illustrate the method of emergency cerclage with the balloon tamponade and demonstrate the efficacy of this surgery method. METHODS: Procedures of the balloon tamponade assisted emergency cerclage were reviewed in detail and outcomes of 39 patients treated with this way were evaluated. RESULTS: From 2017 to 2019, emergency cerclage was successfully performed in 39 patients with a dilated cervix and bulging fetal membranes, assisted by the balloon tamponade. The diameter of the bulging prolapsed membranes ranged from 0.0-10.0 cm, with a median of 2.0 cm. Prolongation of the pregnancy period was from 8 to 138 days, with a median of 29 days. No maternal complications including infections, cervical laceration and cervical bleeding were observed perioperative period. CONCLUSION: Emergency cerclage is an effective way to prolong gestational period in patients with advanced cervical dilatation and bulging membranes. The balloon tamponade assisted emergency cerclage makes the replacement of fetal membranes back into the uterine cavity easier and effectively, then a successful and convenient emergency cerclage can be performed.

The association between intrauterine balloon tamponade volume and postpartum hemorrhage outcomes.

OBJECTIVE: To determine the effect of intrauterine balloon tamponade (IUBT) on the outcomes of postpartum hemorrhage (PPH) according to the balloon volume and to investigate the clinical factors associated with poor PPH outcomes. METHODS: A retrospective cohort study was conducted in which patients with PPH underwent IUBT from January 2016 to August 2018. Patients with an IUBT volume greater than 350 mL (n=76) were compared to patients with an IUBT volume less than 350 mL (n=213). The clinical outcomes related to PPH included blood transfusion, estimated blood loss (EBL) after balloon placement, uterine artery embolization (UAE) after IUBT, and postpartum hospitalization. The results were analyzed by multivariate logistic regression models. RESULTS: None of the clinical outcomes related to PPH and evaluated in our study were favorable in patients with an IUBT volume greater than 350 mL. Other factors associated with poor PPH outcomes after IUBT were placental site hemorrhage, shock index (SI) before IUBT, and antenatal hemoglobin. CONCLUSION: It is better to avoid unnecessary balloon inflation in IUBT if the bleeding is reduced, and more attention should be paid to the procedure when the balloon is large (≥350 mL) than when it is small (<350 mL).

Randomized feasibility study of suction-tube uterine tamponade for postpartum hemorrhage.

OBJECTIVE: To identify an inexpensive catheter suitable for uterine suction tamponade (UST) for postpartum hemorrhage and assess its functionality. METHODS: Randomized, single-center, double-blind feasibility study in East London, South Africa, among 45 women undergoing cesarean delivery between October and November 2018. A search of medical supply websites for catheters with predefined characteristics (inexpensive, flexible, wide-bore, circumferentially-arranged side apertures, rounded tip) identified the FG36 Levin stomach tube. During cesarean, the tube was placed in the uterus and connected transvaginally to a suction unit. Participants were randomized via a computer-generated random sequence to early (after uterine closure; n=24) or delayed (after skin closure; n=21) UST. RESULTS: The tube functioned well with respect to stability in the uterus and aspirating blood from the uterine cavity without blockage. Blood loss was similar between the groups (mean difference, 7.3 mL; 95% confidence interval, -61 to 75; P=0.433), as were secondary outcomes. There were no complications. Absolute effectiveness was not tested because there was no non-suction group. CONCLUSION: The FG36 Levin tube was found to be a suitable device for "suction-tube uterine tamponade". There was no difference in functionality between early and late UST. Future trials should assess the effectiveness of this approach for postpartum hemorrhage. CLINICAL TRIAL REGISTRATION: Registered in the Pan African Clinical Trial Registry as PACTR201809584199573.

Prevention of postoperative adhesion reformation by intermittent intrauterine balloon therapy: a randomised controlled trial.

OBJECTIVE: To compare the efficacy of intermittent intrauterine balloon dilatation versus standard care in the prevention of adhesion reformation. DESIGN: Single-blind randomised controlled trial. SETTING: Hysteroscopic Centre of a tertiary University Hospital. POPULATION: Two hundred patients with moderate to severe (European Society for Gynaecological Endoscopy Grade ≥II) intrauterine adhesions who underwent hysteroscopic adhesiolysis. METHODS: All participants were randomised to a balloon group or a control group postoperatively. The balloon group received intrauterine balloon dilatation therapy at 2 weeks and 6 weeks after surgery, whereas the control group did not. All patients underwent follow-up hysteroscopy at 4 and 8 weeks postoperatively. MAIN OUTCOME MEASURES: The adhesion reformation rate and the Pictorial Blood Loss Assessment Chart scores were analysed. RESULTS: A total of 191 patients successfully completed the study protocol (94 cases for the balloon group and 97 cases for the control group). According to hysteroscopic evaluation at the 8th week, the overall adhesion reformation rate was significantly lower in patients in the balloon group than patients in the control group (20.2% versus 40.2%, respectively; P < 0.05). There was also a significant increase in menstruation flow, as assessed by the Pictorial Blood Loss Assessment Chart score (30 versus 9, respectively; P < 0.001). CONCLUSIONS: Postoperative intermittent intrauterine balloon dilatation therapy can significantly reduce postoperative adhesion reformation and significantly increase menstruation flow. TWEETABLE ABSTRACT: RCT: Postoperative intermittent intrauterine balloon therapy can prevent adhesion reformation after hysteroscopic adhesiolysis.

Comparison of outcome between intrauterine balloon tamponade and uterine artery embolization in the management of persistent postpartum hemorrhage: A propensity score-matched cohort study.

INTRODUCTION: The aim of this study was to compare the outcomes of women who were initially managed by intrauterine balloon tamponade or uterine artery embolization because of persistent postpartum hemorrhage demanding an immediate intervention to control bleeding. MATERIAL AND METHODS: Propensity score-matched cohort study including women who had intrauterine balloon tamponade or uterine artery embolization as initial management strategy to control persistent postpartum hemorrhage, that is, refractory to first-line therapy combined with at least one uterotonic agent. The primary outcome measure was a composite of peripartum hysterectomy and/or maternal mortality. Secondary outcomes measures were total volume of blood loss and total number of packed red blood cells transfused. RESULTS: Our 1:1 propensity score-matched cohort comprised of 50 women who had intrauterine balloon tamponade and 50 women who underwent uterine artery embolization at a blood loss between 1000 and 7000 mL. There was no statistically significant difference in the hysterectomy risk between the two groups (n = 6 in each group, odds ratio [OR] 1.00, 95% confidence interval [CI] .30-3.34), in total volume of blood loss (median 4500 mL, interquartile range [IQR] 3600-5400) for balloon vs 4000 mL (IQR 3250-5000) for embolization, P = 0.382) or in total units of packed red blood cells transfused (median 7 (IQR 5-10) for balloon vs 6 [IQR 4-9] for embolization, P = 0.319). Fifteen women (30%) who were initially managed by an intrauterine balloon still underwent uterine artery embolization, of whom one had an embolization-related thrombo-embolic event. Maternal mortality occurred in neither of the intervention groups. CONCLUSIONS: No difference in the risk of peripartum hysterectomy and/or maternal death was observed between women who had intrauterine balloon tamponade and women who underwent uterine artery embolization as an initial management for persistent postpartum hemorrhage. Although this study was underpowered to demonstrate equivalence, our study design provides a framework for future research in which intrauterine balloon tamponade may prove to be a suitable intervention of first choice in the management of persistent postpartum hemorrhage.

A new approach to fertility-preserving surgery in patients with placenta accreta.

BACKGROUND: The aim of this study was to evaluate the efficacy of a novel combined surgical approach utilising: (1) two autonomous balloon Zhukovsky catheters (vaginal and uterine), (2) bilateral ligation of the descending uterine artery branches, (3) external supraplacental pleated sutures, and (4) either excision of a small area of placenta accreta or full metroplasty, for the management of uterine bleeding associated with placenta accreta of various severity. MATERIALS AND METHODS: The study included medical records of 92 pregnant women with placenta accreta undergoing a caesarean section. To evaluate the efficacy of the proposed management strategy, study participants were divided into three groups. In Group 1 (controls, n = 47), we utilised the combination of bilateral ligation, Barinov external supraplacental pleated sutures, and either excision of the tightly attached portion of placenta accreta or metroplasty. In Group 2 (n = 20), the abovementioned surgical techniques were additionally combined with balloon tamponade using an intrauterine Zhukovsky catheter. In Group 3 (n = 25), we additionally used an intravaginal Zhukovsky balloon catheter to enhance the efficacy of intrauterine tamponade. RESULTS: The use of an intrauterine balloon catheter combined with metroplasty was associated with a reduction in blood loss volume and blood transfusion rate by 1.9-fold, while the use of intravaginal balloon catheter reduced blood transfusion rate by 2.4-fold. The uterine balloon catheter reduced the risk of hysterectomy by 11-fold. CONCLUSION: Simultaneous use of two Zhukovsky balloon catheters (intravaginal and intrauterine) during caesarean section facilitates fertility-preserving surgery in patients with placenta accreta even in the cases of low-segment bleeding, thereby representing a promising approach to management of these patients.

Prognostic factors for the use of intrauterine balloon tamponade in the management of severe postpartum hemorrhage.

OBJECTIVE: To identify prognostic factors associated with successful management of severe postpartum hemorrhage (PPH) using intrauterine balloon tamponade (IUBT). METHODS: Retrospective review of all cases of severe PPH with blood loss greater than 1 L in a tertiary unit in Hong Kong from July 1, 2012, to June 30, 2017. Records of patients who had undergone IUBT insertion were reviewed. Univariate analysis and logistic regression models were used to identify prognostic factors for successful management with IUBT. RESULTS: Of 22 860 deliveries during the study period, severe PPH occurred in 1.4% (n=311), and IUBT was attempted in 26.0% (n=81) of these patients. IUBT alone was successful in arresting hemorrhage in 72.8% (n=59), and the overall rate for avoiding hysterectomy was 86.4% (n=70). Presence of coagulopathy (P=0.048) and placenta accreta (P=0.048) were the adverse prognostic factors associated with higher failure rates. Less blood loss (≤1400 mL) at the time of insertion of IUBT and a positive tamponade test (≤50 mL of blood drained from the uterus within the first 30 minutes after insertion of IUBT) were good predictors for success of IUBT. CONCLUSION: The presence of adverse prognostic factors should prompt early resort to other treatment modalities or hysterectomy as a salvage procedure.

Comparison of results of Bakri balloon tamponade and caesarean hysterectomy in management of placenta accreta and increta: a retrospective study.

The aim of this study was to compare the postoperative results of the patients who were treated with Bakri balloon tamponade or hysterectomy for placenta accreta and increta. Patients who were diagnosed with placenta accreta or increta preoperatively and intraoperatively and treated with Bakri balloon tamponade (Group 1) or caesarean hysterectomy (Group 2) were compared in regards to the postoperative results. Among the 36 patients diagnosed with placenta accreta or increta, 19 patients were treated with Bakri balloon tamponade while 17 cases were treated with hysterectomy. Intraoperative blood loss amount was 1794 ± 725 ml in G1, which was lower than that in G2 (2694 ± 893 ml). Blood transfusion amount was 2.7 ± 2.6 units in G1, lower than that in G2 (5.7 ± 2.4 units), too. Operation time was 64.5 ± 29 min and 140 ± 51 min in G1 and G2, respectively, showing significant differences between two groups. The success rate of Bakri balloon was determined as 84.21%. In conclusion, cases with placenta accreta/increta, with predicted placental detachment who are willing to preserve fertility, application of uterine balloon tamponade devices before the hysterectomy is encouraging with its advantages compared with the hysterectomy. Impact statement What is already known on this subject: Invasive placental anomalies are the most common indication of postpartum hysterectomy. Recently, uterine balloon tamponade was also included in the treatment modalities of postpartum haemorrhage.This study aimed to compare the postoperative results of UBT or hysterectomy for patients with placenta accreta and increta. What the results of this study add: In this study, the total amount of blood loss was higher in the caesarean hysterectomy group when compared with the Bakri balloon tamponade group. The mean transfusion requirement, mean operation time and hospitalisation period was significantly longer in the caesarean hysterectomy group. The success rate of the Bakri balloon was determined as 84.21%. Two patients who were treated with balloon application had a successful pregnancy and delivery later. Maternal mortality was reported in neither balloon nor hysterectomy groups. What the implications are of these findings for clinical practice and/or further research: In conclusion, patients diagnosed with placenta accreta/increta with ultrasound should be taken into the operation in elective conditions, if possible, on lithotomy position. In cases with predicted placental detachment that are willing to preserve fertility, application of uterine balloon tamponade devices before the hysterectomy has advantages compared with the hysterectomy.

Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali.

OBJECTIVE: To assess the effectiveness of low-cost uterine tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings. DESIGN: Randomised controlled trial. SETTING: Seven healthcare facilities in Cotonou, Benin and Bamako, Mali. POPULATION: Women delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics. METHODS: Women were randomly assigned to receive uterine balloon tamponade with a condom-catheter device or no tamponade; both groups were also given intrarectal or sublingual misoprostol. MAIN OUTCOME MEASURE: Proportion of women with invasive surgery or who died before hospital discharge. RESULTS: The proportion of primary composite outcome did not differ significantly between the tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059). TRIAL REGISTRATION NUMBER: ISRCT Registry Number 01202389; Post-results.

El Balón de Bakri como herramienta en el manejo de la hemorragia post parto / THE BAKRI´S BALLOON AS AN IMPORTANT TOOL FOR THE MANAGEMENT OF POST PARTUM HEMORRHAGE

Introducción La hemorragia post parto es una de las complicaciones más graves del puerperio y una de las principales causas de mortalidad materna a nivel mundial. Dentro del esquema del manejo de la misma se encuentra el uso del balón de Bakri para evitar la histerectomía post parto. Objetivo: presentar la experiencia en la utilización del Balón de Bakri en un trabajo colaborativo entre los Servicios de Obstetricia del Hospital Nacional Posadas y de la Madre y el Niño de Formosa Capital entre enero de 2015 a junio de 2016. Método: Estudio transversal y descriptivo que incluyó a 25 pacientes con hemorragia post parto sin respuesta al tratamiento con Ocitócicos y que requirieron colocación del Balón de Bakri. Resultados: El balón de Bakri fue aplicado a 25 mujeres con hemorragia refractaria. La mediana de insuflación del Balón de Bakri fue de 300 (240/ 600 mL). La hemostasia se consiguió en 23 (92 %) de estas mujeres. Dos mujeres debieron ser histerectomizadas por continuar sangrando luego de la colocación del balón. Conclusión: El balón de Bakri es una herramienta eficaz para el manejo de la hemorragia post parto refractaria a carbetocina, evitando la histerectomía en el 92% de los casos.

Postpartum hemorrhage is one of the most serious complications of puerperium and one of the leading causes of maternal mortality worldwide. Within the framework of the management of it is the use of Bakri balloon to prevent puerperal hysterectomy. The aim of this study is to present the experience in the use of Bakri balloon in a collaborative work between the Obstetrics Departments of the Posadas National Hospital and the Madre y el Niño Hospital of Formosa Capital, Argentina, from January 2015 to June 2016. Methods: Cross-sectional descriptive study that included 25 patients with postpartum bleeding with uterine atony refractory to treatment with uterotonics and required Bakri balloon placement. Results: The Bakri ballon was applied to 25 women with refractory bleeding Oxytocics after vaginal delivery. The median Bakri balloon inflation was 300 (240/600 mL). Hemostasis was achieved in 23 (92%) of these women. Two women (8%) had to be undergone hysterectomy for bleeding continue after placement of the ball. Conclusion: The Bakri balloon is an effective tool for the management of post partum hemorrhage refractory to Carbetocin avoiding hysterectomy in 92% of cases.

Uterine packing versus Foley's catheter for the treatment of postpartum hemorrhage secondary to bleeding tendency in low-resource setting: A four-year observational study.

OBJECTIVE: To assess the effectiveness and safety of uterine packing versus Foley's catheter tamponade for controlling postpartum hemorrhage (PPH) secondary to bleeding tendency after vaginal delivery. METHODS: This was a prospective observational study conducted on 92 patients with primary PPH due to bleeding tendency following vaginal delivery who were unresponsive to uterotonics and bimanual compression of the uterus. Patients were divided into two groups, Uterine packing group (n = 45) and Foley catheter group (n = 47). The primary outcome was the success rate of the procedure. Secondary outcome addressed the maternal complications. RESULTS: The use of uterine packing resulted in stoppage of active bleeding in 93.3% of cases compared to only 68.1% in the Foley's catheter group (p < 0.05). Although the rate of minor complications namely fever, pain and urinary complaints were higher in the uterine packing group, it does not reach to a significant difference when compared to the Foley's catheter (p > 0.05). Six cases who failed to Foley catheter tamponade underwent emergency hysterectomy with no cases in the uterine packing group. CONCLUSIONS: The use of uterine packing to arrest PPH is simple, quick and safe procedure to avoid further surgical interventions and to preserve the fertility in low-resource setting.

Condom-catheter tamponade for the treatment of postpartum haemorrhage and factors associated with success: a prospective observational study.

OBJECTIVE: To determine the outcomes and factors associated with postpartum haemorrhage (PPH) treatment with condom-catheter uterine balloon tamponade (C-UBT). DESIGN: Prospective observational study. SETTING: A secondary healthcare facility in Nigeria. POPULATION: Women with PPH refractory to first-line treatment. METHODS: Demographic and clinical characteristics were compared in women with successful and unsuccessful treatment. Univariate and multivariate logistic regression analyses were used to examine the association of these characteristics with successful treatment. MAIN OUTCOME MEASURES: The success rate of C-UBT, factors associated with success, and maternal morbidity rates in both successful and unsuccessful treatment groups. RESULTS: Overall, 203/229 (88.6%) women had successful treatment. Women with successful treatment had lower mean blood loss (1248.8 ± 701.3 ml versus 3434.6 ± 906.6 ml; P < 0.0001), lower occurrence of blood transfusion [139 (68.5%) versus 26 (100%); P < 0.0001], lower intensive care unit admission rates [5 (2.5%) versus 20 (76.9%); P < 0.0001], and lower occurrence of infectious morbidities [3 (1.5%) versus 7 (26.9%); P < 0.0001]. In the regression model with two factors, caesarean section (adjusted odds ratio, aOR 0.17; 95% confidence interval, 95% CI 0.07-0.40) was associated with lower success rates compared with vaginal delivery. In the regression model with three factors, advanced maternal age (aOR 0.31; 95% CI 0.11-0.90) and caesarean section (aOR 0.17; 95% CI 0.07-0.41) were associated with lower success rates in comparison with younger maternal age and vaginal delivery, respectively. CONCLUSIONS: Second-line PPH treatment with C-UBT is effective, and is associated with low maternal morbidity rates. Advanced maternal age and caesarean section are associated with lower success rates. TWEETABLE ABSTRACT: Condom-catheter tamponade is a useful second-line treatment modality for intractable postpartum haemorrhage.